Weekly Digest – August 2026 Weekly Digest – August 2026 21 August 2026: CStone Pharmaceuticals receives NMPA IND approval for CS5007 CStone Pharmaceuticals announced that China’s NMPA has approved the IND application for CS5007, an EGFR/HER3 bispecific ADC, through the […]
Weekly Digest – August 2026 Weekly Digest – August 2026 13 August 2026: Celltrion’s CT-P73 receives US FDA FTD for recurrent/metastatic Cervical cancer Celltrion announced that the U.S. FDA has granted Fast Track designation to CT-P73, a Tissue Factor-targeted ADC, […]
Weekly Digest – August 2026 Weekly Digest – August 2026 10 August 2026: ITM receives Complete Response Letter for ITM-11 ITM announced that the U.S. FDA issued a Complete Response Letter for the NDA of 177Lu-edotreotide, an investigational targeted radiotherapeutic […]
Weekly Digest – August 2026 Weekly Digest – August 2026 13 August 2026: Asieris received FDA IND approval for APL‑2501 for the treatment of advanced Solid tumors Asieris Pharmaceuticals announced that the U.S. FDA has cleared the IND application for […]
Weekly Digest – August 2026 Weekly Digest – August 2026 04 August 2026: U.S. Food and Drug Administration grants Breakthrough Therapy Designation to Multitude Therapeutics’ AMT-253 Multitude Therapeutics announced that the U.S. FDA has granted Breakthrough Therapy Designation to AMT-253, […]
Weekly Digest – August 2026 Weekly Digest – August 2026 05 August 2026: Multitude Therapeutics’ AMT-676 receives Breakthrough Therapy Designation from China’s CDE Multitude Therapeutics’ CDH17-targeted ADC AMT-676 has been granted Breakthrough Therapy Designation by China’s CDE for the treatment […]
Weekly Digest – August 2026 Weekly Digest – August 2026 03 August 2026: TQB2102 receives BTD from the CDE for patients with unresectable or metastatic HER2-low Breast cancer Sino Biopharmaceutical’s next-generation HER2 bispecific ADC TQB2102 has received its third Breakthrough […]
Weekly Digest – August 2026 Weekly Digest – August 2026 03 August 2026: U.S. FDA grants Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan for the treatment of Neuroendocrine Carcinomas Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan has received […]
Weekly Digest – July 2026 Weekly Digest – July 2026 28 July 2026: DualityBio and BioNTech’s B7-H3 ADC DB-1311 granted China NMPA BTD for metastatic castration-resistant Prostate cancer DualityBio and BioNTech announced that China’s NMPA has granted Breakthrough Therapy Designation […]
Weekly Digest – July 2026 Weekly Digest – July 2026 24 July 2026: Gilead announces CHMP recommendation for Trodelvy + Keytruda in 1L PD-(L)1+ mTNBC Gilead announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has […]
